An appeals court in the United States has ruled that the patent that Johnson & Johnson holds for Remicade, a top-selling treatment for arthritis, is invalid. According to the appeals court the antibodies that were covered by the patent had already been disclosed in a patent that had been published earlier.
The move by the appeals court to uphold the decision made by U.S. Patent and Trademark Office, is a blow to the pharmaceutical giant and its Remicade treatment as it is the top-selling drug of the company. In a statement Johnson & Johnson said that the court’s ruling was disappointing and warned that the decision by the appeals court would have implications on other pharmaceutical firms.
“We believe that biopharmaceutical intellectual property protections, such as patents and data protection, enable us to invest in the discovery and development of tomorrow’s life-changing and life-saving new medicines,” a statement from Johnson & Johnson said.
Per Johnson & Johnson Remicade has assisted over 2.6 million people spread across the globe. Despite the setback the pharmaceutical giant gave assurances that it would ensure that the arthritis team remained affordable and accessible to patients.
Challenging the patent was Pfizer’s Hospira, a firm which owns the exclusive marketing rights in the United States for a biosimilar known as Inflectra and which was developed by South Korean drugmaker, Celltrion Inc. Pfizer welcomed the ruling after it was delivered saying it was in the best interest of patients.
Besides Inflectra which was unveiled two years ago, Remicade has other biosimilars competing with it in the United States. Sales of Inflectra have been slow and in 2017 Johnson & Johnson was accused of antitrust violations by Pfizer with regards to how Remicade was being sold.
Unlike the case of generic drugs where recipes for the original treatment are directly copied, biosimilars involve advanced manufacturing skills as well as greater testing. But still biosimilars piggyback on the efficacy and safety tests of the original drug making them cheaper to develop. In the event that Johnson & Johnson had won the appeal leading to the revival of its patent, it would have been placed in a position to demand manufacturers of the biosimilars offer compensation for profits it might have lost to rivals.
The ruling by the U.S. appeals court comes in the wake of Johnson & Johnson’s cancer treatment Zytiga being declared invalid by a patents board. Johnson & Johnson has vowed to lodge an appeal with the Federal Circuit.